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510(k) K200120

LiteSaber Wire Torque Assist Device by Vesatek, LLC — Product Code DQX

K200120 is an FDA 510(k) premarket notification submitted by Vesatek, LLC for the device "LiteSaber Wire Torque Assist Device". The FDA issued a decision of Substantially Equivalent on May 7, 2020. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Vesatek, LLC has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2020
Date Received
Jan 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type
510(k)

Other clearances by Vesatek, LLC

  • K170684 — Firebow Wire Torque Assist Device (Jun 29, 2017)

Other clearances for product code DQX

  • K253146 — Hyperdrive 35 Guidewire (Sep 18, 2026)
  • K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (Sep 3, 2026)
  • K253667 — Accoat Guide Wire (Jul 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (Jul 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered… (Mar 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (Mar 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (Mar 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (Jan 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire… (Jan 21, 2026)

FDA data resources